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| ID | Type | Description | Link |
|---|---|---|---|
| Pro2020000712 | Other Identifier | Rutgers Health Sciences IRB | |
| Pro2020000712 | Other Identifier | Rutgers Cancer Institute of New Jersey |
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Ineffectiveness of treatment
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This is a three-arm randomized trial comparing the efficacy of single agent hydroxychloroquine to the combination of hydroxychloroquine and azithromycin, and to a delayed hydroxychloroquine regimen, which will serve as a contemporaneous Day 1-6 supportive care control, in eliminating detectable SARS-CoV-2 on day 6 following the initiation of treatment in order to determine which regimen is more effective.
PRIMARY OBJECTIVE:
I. Determine change in viral load at day 6 compared to baseline between two regimens to treat COVID-19 and a contemporaneous control group.
SECONDARY OBJECTIVES:
I. Time to resolution of symptoms (symptom questionnaire)
II. Change in the fever curve resulting in shorter time to afebrile for 48 hours
III. Normalization of vital signs
IV. Time to discharge (if hospitalized)
V. Assessment of agent toxicity as measured by standard metrics
VI. Collection of throat swab and blood for viral load, presence of IgM or IgG antibodies
VII. If feasible on samples collected for quantitative PCR decrease in virus shedding (in oropharyngeal secretions)
VIII. Measures of cytokines in blood including IL6, IL-8, TNF, INF
IX. Routine standard of care labs obtained as part of the care of these patients such as differential white count, CRP, troponin and LFTs will be analyzed for correlative trends
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Hydroxychloroquine Sulfate + Azithromycin | Experimental |
|
|
| Arm 2: Hydroxychloroquine Sulfate alone | Experimental | • Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days |
|
| Arm 3: Placebo | No Intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine Sulfate + Azithromycin | Combination Product | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Patients Viral Load | Will be assessed at day six compared to baseline between hydroxychloroquine sulfate alone and hydroxychloroquine sulfate plus azithromycin to treat COVID-19. | Baseline and day six |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sabiha Hussain, MD | Rutgers, The State University of New Jersey | Principal Investigator |
| Steven K. Libutti, MD, FACS | Rutgers Cancer Institute of New Jersey | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | United States | ||
| Robert Wood Johnson University Hopsital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Hydroxychloroquine Sulfate + Azithromycin |
Hydroxychloroquine Sulfate + Azithromycin: Given PO Hydroxychloroquine Sulfate: Given PO |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2020 | Sep 20, 2022 |
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| Hydroxychloroquine Sulfate | Drug | Given PO |
|
|
| New Brunswick |
| New Jersey |
| 08901 |
| United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| The University Hospital | Newark | New Jersey | 07103 | United States |
| University Hospital-Newark | Newark | New Jersey | 07112 | United States |
| FG001 |
| Arm 2: Hydroxychloroquine Sulfate Alone |
• Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days Hydroxychloroquine Sulfate: Given PO |
| FG002 | Arm 3: Placebo |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Hydroxychloroquine Sulfate + Azithromycin |
Hydroxychloroquine Sulfate + Azithromycin: Given PO Hydroxychloroquine Sulfate: Given PO |
| BG001 | Arm 2: Hydroxychloroquine Sulfate Alone | • Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days Hydroxychloroquine Sulfate: Given PO |
| BG002 | Arm 3: Placebo |
|
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Patients Viral Load | Will be assessed at day six compared to baseline between hydroxychloroquine sulfate alone and hydroxychloroquine sulfate plus azithromycin to treat COVID-19. | Data were not collected | Posted | Baseline and day six |
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The period of time over which adverse event data was collected is after six days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Hydroxychloroquine Sulfate + Azithromycin |
Hydroxychloroquine Sulfate + Azithromycin: Given PO Hydroxychloroquine Sulfate: Given PO | 4 | 16 | 0 | 16 | 7 | 16 |
| EG001 | Arm 2: Hydroxychloroquine Sulfate Alone | • Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days Hydroxychloroquine Sulfate: Given PO | 4 | 30 | 1 | 30 | 13 | 30 |
| EG002 | Arm 3: Placebo |
| 1 | 29 | 1 | 29 | 5 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Investigations | Investigations | Systematic Assessment |
| ||
| Infections and infestations | Infections and infestations | Systematic Assessment |
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| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Systematic Assessment |
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| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sabiha Hussain | Cancer Institute of New Jersey | +1 732-718-3253 | hussaisa@rwjms.rutgers.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 8, 2020 | Sep 20, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: ICF #1 | Apr 21, 2020 | Aug 15, 2022 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: ICF #2 | Apr 21, 2020 | Aug 15, 2022 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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